Coronary Artery DiseaseNCT04961606
Exercise Adherence of Home-based Cardiac Rehabilitation
An observational study of Coronary Artery Disease, run by Peking University Third Hospital at 1 site in China.
Trial summary
The study explored the influencing factors of exercise adherence of home-based cardiac rehabilitation in patients with coronary artery disease. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- interview
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 3 Nov 2020to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with coronary artery disease and medical professionals in home-based cardiac rehabilitation
Who may be able to join
- Diagnosis of coronary artery disease;
- Age ≤75 years old;
- Participated in home-based cardiac rehabilitation ≥12 weeks;
- Have good language skills;
- Volunteer to participate in this study.
Who cannot join
- Have other serious acute or chronic diseases;
- A previous history of mental illness or a positive family history of mental illness;
- Have severe audio-visual or speech impairments that may affect understanding and answering questions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Qualitative Research on the Influencing Factors of Exercise Adherence of Home-based Cardiac Rehabilitation in Patients With Coronary Artery Disease
The study explored the influencing factors of exercise adherence of home-based cardiac rehabilitation in patients with coronary artery disease.
Read the detailed description
The study used a qualitative exploratory design. Informants were recruited by purposive sampling. Semi-structured individual interviews were conducted among patients with coronary artery disease and medical professionals in home-based cardiac rehabilitation.
- Conditions
- Coronary Artery Disease
- Being tested
- interview
- Keywords
- Coronary artery disease, Home-based cardiac rehabilitation, Exercise adherence
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviewOther
semi-structured individual interview
| Study group | Role | What they receive |
|---|---|---|
| patients with coronary artery disease | Not described Receives: Other: interview | |
| medical professionals | Not described Receives: Other: interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influencing factors of exercise adherence
Influencing factors of exercise adherence in home-based cardiac rehabilitation
Measured: The influencing factors of exercise adherence in home-based cardiac rehabilitation will be measured by the construct of the theory of planned behavior through study completion, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start3 Nov 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Zhao, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961606
- Sponsor's protocol ID
- IRB00006761-M2020452
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Research on the Influencing Factors of Exercise Adherence of Home-based Cardiac Rehabilitation in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT04961606
- Acronym / sponsor ID
- IRB00006761-M2020452
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Home-based cardiac rehabilitation, Exercise adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study explored the influencing factors of exercise adherence of home-based cardiac rehabilitation in patients with coronary artery disease.
Detailed description
The study used a qualitative exploratory design. Informants were recruited by purposive sampling. Semi-structured individual interviews were conducted among patients with coronary artery disease and medical professionals in home-based cardiac rehabilitation.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with coronary artery disease | – | Other: interview |
| medical professionals | – | Other: interview |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with coronary artery disease and medical professionals in home-based cardiac rehabilitation
Key inclusion criteria (5 listed)
- Diagnosis of coronary artery disease;
- Age ≤75 years old;
- Participated in home-based cardiac rehabilitation ≥12 weeks;
- Have good language skills;
- Volunteer to participate in this study.
Key exclusion criteria (3 listed)
- Have other serious acute or chronic diseases;
- A previous history of mental illness or a positive family history of mental illness;
- Have severe audio-visual or speech impairments that may affect understanding and answering questions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interviewsemi-structured individual interview | Other | medical professionals, patients with coronary artery disease |
Primary outcome
Influencing factors of exercise adherence
Time frame: The influencing factors of exercise adherence in home-based cardiac rehabilitation will be measured by the construct of the theory of planned behavior through study completion, an average of 5 months
Influencing factors of exercise adherence in home-based cardiac rehabilitation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Zhao study director
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influencing factors of exercise adherence (time frame: The influencing factors of exercise adherence in home-based cardiac rehabilitation will be measured by the construct of the theory of planned behavior through study completion, an average of 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.